The WHO Medicines Strategy 2008-2013

1. The WHO Medicines Strategy 2008-2013 Kees de Joncheere Essential Medicines and Health products November 2012

2. Outline of the presentation • The global pharmaceutical scene, and the strategic landscape • The WHO Medicines Strategy for 2008-2013: • Access • Quality • Rational use • The Essential Medicines Family • Potential areas of collaboration

3. Trends in global pharmaceutical situation,challenges for 2008-2013 (1) • Recognition that disease-oriented vertical programmes need an integrated approach with horizontal health systems, supply systems • More interest in medicine regulation and quality assurance systems; this implies the need for practical global standards and support to national regulatory agencies • Global funding mechanisms for essential medicines; these need global health policy direction, global standards and technical support from WHO • More players and partnerships, changing the landscape; these need a multi-stakeholder ("MOH-plus") approach and coordination at country level

4. Trends in global pharmaceutical situation,new challenges for 2008-2013 (2) • IPR interest moving from global TRIPS discussion towards technical support to countries; focus on innovation and public health • Move towards Universal Health Coverage and with it comprehensive policies on access to medical products • WHO Reform and DG priorities : PHC and UHC, Access to medical products, Africa, women and children, NCD • Recent WHA resolutions (prices, IPR, rational use, medicines for children, SSFFC, UHC); this implies the need for additional funding to expand work in these areas

5. Example of impact of earlier Medicine Strategies:

6. Examples of country progress in supply:

7. WHO Medicines Strategy 2008-2013Strategic landscape • Experiences from 2000-03 and 2004-07 Medicine Strategies • Millennium Development Goals 2000-2015 • WHO Medium Term Strategic Plan 2008-2013 • Strategic Objective 11 covers access, quality, rational use • Recent WHA resolutions • Rational use, EMs for children, Global strategy on PH/I/IP 2008-15, SSFFC, UHC, NCDs, … • Stated priorities of the Director-General • NCDs, Women and children, UHC, Access to medical products • Global Programme of Work 2014-2018 and post-MDG agenda

8. Strategic landscape:Medicine-related Millennium Development Goals

9. (Quantified intuition) New standard set of indicators for measuring access for WHO/MTSP, UNDP/MDG8 Gap Analysisand Lancet assessment Government commitment: • Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation (S) • Existence and year of a published national medicines policy (S) Rational selection: • Existence and year of a published national list of essential medicines (S) Affordable prices: • Legal provisions to allow generic substitution in private sector (S) • Median consumer price ratio of 30 selected EMs in pub/private facilities (P) • Percentage mark-up between manufacturers' and consumer price (P) Sustainable financing: • Public and private per capita expenditure on medicines (P) • % of population covered by national health service or health insurance (P) Reliable systems: • Average availability of 30 selected EMs in public/private health facilities (O)

10. WHO strategic directions in medicines1: Policy, access (1) • National medicine policies: Continue strengthening national policies; new focus on comprehensive PHC, health insurance, UHC; • Intellectual Property Rights: Global discussions to continue; provide technical support to countries; new focus on IPR and innovation, renewed interest in local production • Traditional medicine: Continue support on regulating quality and safety; new focus on integrating with allopathic medicine policies, promoting evidence on efficacy, regulating products and professionals • Access: New focus on separate access indicators and on activities to promote availability, price and affordability

11. WHO strategic directions in medicines1: Policy, access (2) • Comprehensive supply systems: Continue promotion of best practices; focus on system building with procurement and supply, how to work with private sector, reimbursement arrangements, implementing policies on pricing of medicines • Transparency and good governance: New policy guidance on transparency and good governance in national pharmaceutical systems • Information and planning: Improve indicators and household surveys; new link with NHAs, IMS-data, IEP surveys to create package of country data and improve planning; new focus on sex-disaggregated statistics • Global funding mechanisms: Continue country support; new focus on guidance and technical support

12. WHO strategic directions in medicines2: Regulation and Quality (1) • Nomenclature: Continue INN and other nomenclatures; new focus on methods to assign names to biological products • Controlled drugs: Continue Treaty obligations on scheduling substances for international controls; focus on improving access to controlled medicines • Quality: Continue normative work (Expert Committees); the International Pharmacopeia; new focus on missing EMs for priority diseases and children; • Prequalification: Continue PQ of priority medicines; new focus on QClabs, APIs, CROs; advice to diagnostics, RH commodities, vaccines; strong focus on capacity building

13. WHO strategic directions in medicines2: Regulation and Quality (2) • Strengtheningnational regulatory authorities and regulatory networking : ICDRA, regional and subregional initiatives, new drive towards global collaboration and convergence in medicines and medical products regulation • Combating SSFFC counterfeit medical products : designing and implementing a new Member State Mechanism • Pharmacovigilance: Continue global ADR programme; new focus on disease-specific cohort methods for priority diseases (malaria, HIV) and active steering of new global interest in pharmacovigilance

14. WHO strategic directions in medicines3: Rational use • Selection: Continue evidence-based Model List and EM Library; next meeting April 2013; include focus on EMs for children, methodological guidance within WHO (Guidelines Review Committee ) • Rational use: • Continue global database on medicines use indicators; • new focus on national RU programmes (situation analysis, multi-stakeholder approach, comprehensive health systems, national RU body); • new focus on antimicrobial resistance and adherence to chronic treatment;

15. World Medicines Situation 2011 • The third edition of the World Medicines Situation Report brings together new data on 24 key topics relating to pharmaceutical production and consumption, innovation, regulation and safety - in one place. • Topics include selection, procurement, supply management, rational use, financing and pricing. Cross-cutting chapters cover household medicines use, access and human rights, good governance, human resources and national medicines policies. • Each chapter of this report is written by a different author. Chapters are being published electronically, in batches, between April and December 2011. The new report updates the 1988 and 2004 reports.

16. Introduction Global health trends: global burden of disease and pharmaceutical needs Pharmaceutical consumption Medicine expenditures Released August 2011 Financing medicines Medicines prices, availability and affordability Released April 2011 Access to medicines at the household level (access to health care and medicines: burden of expenditures and risk protection) Research and development of medicines Intellectual property, trade and medicines Regulation of medicines prices Quality of medicines: the challenge of globalization Pharmacovigilance and Safety of Medicines Released August 2011 Selection of Essential Medicines Released August 2011 Rational use of medicines Released April 2011 Medicines Information and regulation of promotion Procurement of Medicines Released August 2011 Storage and supply chain management of medicines Traditional medicines: global situation, issues and challenges Released April 2011 Access to controlled medicines Released April 2011 Good governance of pharmaceutical Sector Released April 2011 Human resources in pharmaceuticals Access to Essential Medicines as Part of the Right to Health Released August 2011 National medicines policy Conclusion World Medicines Situation 2011

17. Global Medicines Family • Geneva: Department of Essential Medicines and Health products EMP (about 100 staff) • Six regional offices: 2-5 professionals per office • 40 of 100 WHO country offices have full-time pharmaceutical policy experts (about half of them funded through EC funds) • Many external networks: • Six Expert Advisory Panels (quality, policy, narcotics, selection, etc) • About 50 WHO Collaborating Centres (centres of excellence) • Regulators, inspectors, laboratories, INRUD, HAI, safety, INN, pricing • E-drug, Re-med, e-farmacos, india-drug, etc (over 8000 subscribers) • Mednet • Interagency Pharmaceutical Coordination (all UN agencies)

18. WHO/EMP has many collaboration and implementation channels WHO Department of EMP IPC WHO: HIV, MAL, TB, RH, MSD,CAH, HSS (Trad Med) UN: UNICEF, UNAIDS, UNFPA, WBank, GFATM, WIPO, etc NGOs: MSF, HAI, MSH, JSI churches, networks, WMA, FIP, IGPA, IFPMA, WSMI, etc Regional Offices Country Offices MOH Outside MOH: Drug regul. agency, insurance, collab.centers, universities, missions, NGOs, consumers National programmes for health professionals, patients and consumers

19. Essential Medicines and Health Products EMP : Kees de Joncheere, Director MAR Medicine Access and Rational Use C.Ondari, Coordinator QSM Quality and Safety: Medicines L.Rägo, Coordinator MPC Medicine Programme Coordination G.Forte, Coordinator Incorporating MIE DIM and DLT Essential Health Technology & Medical devices Gaby Vercauteren and Adriana Velazquez, Coordinators • INN programme • Quality Assurance • Safety and Efficacy • Prequalification • Assessment • Inspection • Capacity building • Regulatory support • Blood products and related biologicals • Selection of Ess. medicines • Pricing and financing • Supply management • Rational Use • Controlled medicines • Country programme coordination & support • Policy guidance • Country profiles • Good governance & MeTA • Prequalification of Diagnostics • Policy guidance on Technology and medical devices • Country Surveys • HTA

20. Conclusion: Essential Medicines in November 2012 Good news: • Working towards a new Essential Medicines Action Plan 2014 -2018 • Better access indicators now used for UN/MDGs, and national programmes • Global norms/standards, prequalification, WHO/HAI pricing methods, • 80 country projects and innovative public health thinking lead to solid international reputation, trust by Member States Bad news: • Financial uncertainty • RB + CVC 10-15%, Specified Project Funding >80%, and “pockets of poverty” , i.e. rational use, supply issues